PMA P060033S038
- Device
- ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S038
- Product code
- NIQ
- Decision date
- 2009-10-19
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- APPROVAL FOR A 24 MONTH SHELF LIFE FOR ENDEAVOR SPRINT.
Current openFDA PMA Record
- Device
- ENDEAVOR AND ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Inc.
- PMA number
- P060033
- Supplement
- S038
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2009-10-19
- Decision code
- APPR
- Date received
- 2009-08-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A 24 MONTH SHELF LIFE FOR ENDEAVOR SPRINT.